Cleared Traditional

K952622 - CRYO CHECK NORMAL HUMAN REFERENCE PLASMA

K952622 is the FDA 510(k) clearance for CRYO CHECK NORMAL HUMAN REFERENCE PLASMA by Precision Biologicals, Inc.. It is a Class 2 Hematology device (product code GGN) cleared through the Traditional 510(k) pathway after a 144-day FDA review.

K952622 · Precision Biologicals, Inc. · Hematology device
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Oct 1995
Decision
144d
Days
Class 2
Risk

K952622 is an FDA 510(k) clearance for the CRYO CHECK NORMAL HUMAN REFERENCE PLASMA. Classified as Plasma, Coagulation Control (product code GGN), Class II - Special Controls.

Submitted by Precision Biologicals, Inc. (Dartmouth, Nova Scotia, CA). The FDA issued a Cleared decision on October 30, 1995 after a review of 144 days - within the typical 510(k) review window.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.5425 - the FDA hematology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Hematology review framework, consistent with the majority of Class II 510(k) submissions.

View all Precision Biologicals, Inc. devices

Submission Details

510(k) Number K952622 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 08, 1995
Decision Date October 30, 1995
Days to Decision 144 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
31d slower than avg
Panel avg: 113d · This submission: 144d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code GGN Plasma, Coagulation Control
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 864.5425
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Hematology devices follow this clearance model.

Regulatory Peers - GGN Plasma, Coagulation Control

All 56
Devices cleared under the same product code (GGN) and FDA review panel - the closest regulatory comparables to K952622.
STA - VWF CONTROL [N]+[P] KIT
K962674 · American Bioproducts Co. · Jul 1996
BEHRING COAGULATION TIMER
K955278 · Behring Diagnostics, Inc. · May 1996
PORCINE FACTOR VIII
K952321 · Helena Laboratories · Mar 1996
ORTHO ASSAYED REFERENCE PLASMA-NORMAL/ PLASMA-ABNORMAL
K940209 · Ortho Diagnostic Systems, Inc. · May 1995
STA SYSTEM CONTROL [N] + [P] KIT
K943518 · American Bioproducts Co. · Mar 1995
ITC WHOLE BLOOD CONTROL NORMAL/ABNORMAL LEVEL I OR II
K944691 · International Technidyne Corp. · Mar 1995